Tony Mazzeo
About Tony Mazzeo
Tony Mazzeo is the Associate Scientific Director at Bristol-Myers Squibb, with over 17 years of experience in pharmaceutical stability strategy and regulatory submissions.
Title
Tony Mazzeo holds the position of Associate Scientific Director at Bristol-Myers Squibb. In this role, he is responsible for overseeing various scientific initiatives and projects within the organization.
Company
Tony Mazzeo is currently employed at Bristol-Myers Squibb, a renowned global biopharmaceutical company known for its commitment to discovering, developing, and delivering innovative medicines. He has been with the company since June 2006, contributing to its scientific direction and strategic goals.
Education and Expertise
Tony Mazzeo completed his undergraduate studies at SUNY Brockport, earning a BS in Chemistry in 1980. He furthered his education at Syracuse University, where he earned a PhD in Chemistry in 1988. With over 17 years of experience in pharmaceutical stability strategy, he has a deep knowledge of small molecules and biologics.
Experience in Regulatory Submissions
Tony specializes in Chemistry, Manufacturing, and Controls (CMC) authoring for regulatory submissions, including Investigational New Drug (IND), Clinical Trial Application (CTA), New Drug Application (NDA), and Biologics License Application (BLA). His expertise in this area ensures compliance with regulatory standards and supports the successful approval of pharmaceutical products.
GMP Stability Sample Management
In his role, Tony Mazzeo manages Good Manufacturing Practice (GMP) stability samples and conducts quality investigations. His work ensures that pharmaceutical products maintain their stability and efficacy throughout their shelf life, adhering to stringent regulatory requirements.
Lean Sigma Methodologies and Cold Chain Support
Tony utilizes Lean Sigma methodologies for continuous improvement and efficient project management. He also provides cold chain support, ensuring that pharmaceutical products are stored and transported under optimal temperature conditions, which is critical for maintaining their integrity and effectiveness.
Interaction with Health Authorities
As part of his responsibilities, Tony interacts regularly with health authorities, facilitating communication and ensuring regulatory compliance. His role involves addressing queries and providing necessary documentation to aid in the evaluation and approval processes of pharmaceutical products.